Comparison of the Effects of Continuous Epidural Analgesia and Continuous Intravenous Analgesia on Postoperative Bowel Movement in Patients Undergoing Laparoscopic Gastrectomy

Gastric Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02458573
• Other study ID #: 4-2015-0157
• Status: Completed
• Phase: Phase 4
• First received: May 26, 2015
• Last updated: January 24, 2017
• Start date: June 4, 2015
• Est. completion date: March 28, 2016

Study information

• Verified date: January 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesized that sympatholytic effect of epidural analgesia would attenuate the hemodynamic instability and decrease in the splanchnic blood flow caused by pneumoperitoneum during laparoscopic surgery. This study is to compare the effect of epidural analgesia and intravenous analgesia on postoperative bowel movement in patients undergoing laparoscopic gastrectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: March 28, 2016
• Est. primary completion date: March 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• patient between 20 and 70 of age with ASA physical status ?-?

• gastric cancer patient undergoing laparoscopic gastrectomy

Exclusion Criteria:

• ASA physical status ?

• bradycardia (< 60 bpm), arrhythmia

• uncompensated heart failure

• hepatic failure (Child-Pugh score B)

• renal failure (eGFR MDRD < 60 ml/min/1.73m2)

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Other:
• continuous epidural analgesia
the continuous epidural analgesia group: epidural analgesia started from induction of anesthesia and continued for 48 h.
• continuous intravenous analgesia
the continuous intravenous analgesia group: intravenous analgesia started from induction of anesthesia and continued for 48 h.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the time to first gas passing after surgery	Outcome will be assessed by a investigator blinded to the study group.	within 5days after surgery
Primary	the time to resume water intake after surgery	Outcome will be assessed by a investigator blinded to the study group.	within 5days after surgery
Primary	soft diet intake after surgery	Outcome will be assessed by a investigator blinded to the study group.	within 5days after surgery
Secondary	postoperative pain	numerical rating scale 0 (no pain) to 10 (worst pain)	immediately after surgery to 48 hours